Nearly 20 years ago, Myriad obtained several pa­tents after discovering the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which can dramatically in­crease the risk of breast and ovarian cancer. This knowledge enabled Myriad to develop medical tests for detecting muta­tions in these genes to assess a patient’s cancer risk.

The validity of the patents was challenged by a consortium of interested parties. Cancer patients and medical associations were anxious to reduce the cost of such genetic testing, which can run as high as $US 4,000. Scientists raised concerns over restrictions on their ability to use the genes for research, and the impact this had on the free flow of scientific information.

On 13 June 2013, the Supreme Court held that a naturally occurring DNA segment is a product of nature and not patent-eligible merely because it has been isolated. However, synthetic genetic material known as complementary DNA (cDNA) can be patented because it is not naturally occurring. This means that Myriad no longer has the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes, but it can claim exclusive rights to synthetically create BRCA cDNA.

Until the ruling, Myriad held a monopoly on testing for BRCA genes - an issue which was recently brought to the public’s attention with actress Angelina Jolie’s announcement that she had a double mastectomy after testing positive for one of the genes.

The US Patent Act (section 101) permits patents to be issued to in­venters or discoverers of any new and useful composition of matter, but the court held that ‘laws of nature, natural phenomena, and abstract ideas are basic tools of scientific and technological work that lie beyond the domain of patent protection’.

The court explained that without this exception, there would be a danger that the grant of patents would tie up the use of such tools and inhibit future innovation premised upon them. ‘This would be at odds with the very point of patents, which exist to promote creation,’ Thomas J concluded.

Delivering a unanimous judgment for the Supreme Court, Thomas J emphasised that ‘patent protection strikes a delicate balance between creating incen­tives that lead to creation, invention, and discovery, and impeding the flow of information that might permit, indeed spur, invention.’ This standard was used to determine whether Myriad’s pa­tents claim a new and useful composition of matter or claim naturally occurring phenomena.

Myriad’s DNA claim was found to fall within the law of nature exception. While Myriad found an im­portant and useful gene, ‘ground breaking, innovative, or even brilliant discovery’ and extensive effort was not enough to satisfy the ‘new and useful composition of matter’ requirement.

‘Myriad did not create anything’ with isolated DNA, according to Thomas J, as separating the gene from its surrounding genetic material was not an act of invention. However, the cDNA at issue is not a ‘product of nature’, as the lab technician created something new and complementary to the BRCA gene, making it is patent-eligible.

While seen as something of a compromise, this ruling could have profound implications for the biotechnology and drug industry. Myriad’s patents were due to expire over the coming years due to the 20-year limit on patents, but the decision has implications far beyond the scope of the BRCA1 and BRCA2 patents.

Concerns have been raised that it could discourage investment in genetic research by taking away commercial incentive to continue researching into DNA. Some biotech research companies saw it as an about-turn in the international approach to intellectual property rights surrounding genetics.

The US Supreme Court decision forces a change at the US Patent and Trademark Office, which has been awarding gene patents since 1982.

It also contradicts a ruling on gene patenting in Australia's Federal Court in February this year, which decided in favour of Myriad after a similar lawsuit was brought by Cancer Voices Australia. The Federal Court ruled that the two genes, extracted from natural cells obtained from the human body and 'purged of other biological materials,' constituted a 'manner of manufacture' and could therefore be patented’. That decision has been appealed to the Full Court of the Federal Court, with a hearing expected in August.

The Australian Federal Court is not legally bound to follow the US Supreme Court decision, but will no doubt closely examine the US Supreme Court decision in its deliberations.

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Comments

21/01/2014 1:53 PM

Flabmeister said:

AS well as a monopoly, do Myriad have a patent for the testing process?

21/01/2014 1:53 PM

Genevieve Butler said:

Myriad held patents on the tests from the late 1990s until the Supreme Court decision in Association for Molecular Pathology v Myriad Genetics. The ruling invalidated five patents held by Myriad, which underpinned Myriad’s BRACAnalysis test, thus breaking Myriad's monopoly on BRCA testing. One of the effects of the case was to open the market for testing to competition. Several other companies immediately said they would offer such tests at a lower cost.

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Flagpost is a blog on current issues of interest to members of the Australian Parliament